FOLFOX-HAIC Plus Lenvatinib and Toripalimab vs. FOLFOX-HAIC Plus Lenvatinib for Advanced Hepatocellular Carcinoma: a Randomized Controlled and Double-blind Trial
- Conditions
- Hepatocellular Carcinoma
- Interventions
- Procedure: Hepatic arterial infusion chemotherapy
- Registration Number
- NCT06201065
- Lead Sponsor
- Sun Yat-sen University
- Brief Summary
Our previous study showed that hepatic arterial infusion chemotherapy plus lenvatinib and toripalimab improved the survival of advanced hepatocellular carcinoma. However, Leep 002 study showded that lenvatinib plus PD-1 antibody is not superior to lenvatinib alone for advanced hepatocellular carcinoma. Thus, wo conduct this study to compare hepatic arterial infusion chemotherapy plus lenvatinib and toripalimab with hepatic arterial infusion chemotherapy plus lenvatinib for advanced hepatocellular carcinoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
- Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria.
- Barcelona clinic liver cancer-stage C
- Eastern Cooperative Oncology Group performance status of 0 to 2
- With no previous treatment
- No Cirrhosis or cirrhotic status of Child-Pugh class A only
- Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
- This study did not limit HBV DNA load. High HBV-DNA load was aollowed, but hepatitis-B patient must receive concurrent antiviral therapy.
- The following laboratory parameters:
Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 30 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3
• Ability to understand the protocol and to agree to and sign a written informed consent document
- Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
- Known history of HIV
- History of organ allograft
- Known or suspected allergy to the investigational agents or any agent given in association with this trial.
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
- Evidence of bleeding diathesis.
- Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
- Known central nervous system tumors including metastatic brain disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental arm oxaliplatin , fluorouracil, and leucovorin Hepatic arterial infusion chemotherapy plus lenvatinib and toripalimab Experimental arm Lenvatinib Hepatic arterial infusion chemotherapy plus lenvatinib and toripalimab Experimental arm Toripalimab Hepatic arterial infusion chemotherapy plus lenvatinib and toripalimab Control arm Hepatic arterial infusion chemotherapy Hepatic arterial infusion chemotherapy plus lenvatinib Experimental arm Hepatic arterial infusion chemotherapy Hepatic arterial infusion chemotherapy plus lenvatinib and toripalimab Control arm oxaliplatin , fluorouracil, and leucovorin Hepatic arterial infusion chemotherapy plus lenvatinib Control arm Lenvatinib Hepatic arterial infusion chemotherapy plus lenvatinib
- Primary Outcome Measures
Name Time Method Overall Survival (OS) 18 months OS was defined as the duration from the date of randomization until the date of death from any cause. Participants who were lost to follow-up were censored at the last date the participant was known to be alive, and participants who remained alive were censored at the time of data cutoff.
- Secondary Outcome Measures
Name Time Method Objective Response Rate (ORR) 18 months ORR was defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR) based on mRECIST. CR was defined as disappearance of any intratumoral arterial enhancement in all target lesions. PR was defined as at least a 30% decrease in the sum of diameters of viable (enhancement of arterial phase) target lesions taking as reference to the baseline sum of the diameters of target lesions.
Progression Free Survival (PFS) 18 months PFS was defined as the time from the date of randomization to the date of first documentation of disease progression based on modified Response Evaluation Criteria in Solid Tumors (mRECIST), or date of death, whichever occurred first.
Adverse Events 30 days Number of adverse events. Postoperative adverse events were graded based on CTCAE v4.03
Trial Locations
- Locations (1)
Cancer Center Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China